Sr. Director, Operations Quality Management

Responsibilities

• Lead and oversee all Quality functions at the El Paso site, ensuring full compliance with regulatory requirements including 21 CFR Parts 210, 211, 820, EU GMP, and ICH guidelines.
• Serve as the site Quality Head and Management Representative, providing strategic leadership for the Quality Management System (QMS).
• Define and execute the site Quality Strategy in alignment with global business objectives and regulatory expectations.
• Manage regulatory remediation situations, including warning letters, response strategies, and cross-functional governance to restore compliance.
• Lead regulatory inspections (FDA, EMA, MHRA, etc.) and ensure the site maintains a constant state of inspection readiness.
• Drive timely, thorough, and scientifically sound investigations, ensuring appropriate root cause identification and effective CAPA implementation.
• Partner with Manufacturing, Engineering, and R&D to ensure process robustness, validation lifecycle compliance, and successful technology transfers.
• Lead risk assessments related to product quality and patient safety, including field impact evaluations and health hazard assessments.

Requirements

• Bachelor’s degree in Science, Engineering, or a related discipline.
• Minimum 10+ years of experience in the regulated pharmaceutical industry.
• Minimum 5+ years in leadership roles within a Quality organization.
• Demonstrated experience managing regulatory inspections and formal responses.
• Expert knowledge of 21 CFR Parts 210/211/820, EU GMP (including Annex 1), and ICH Guidelines (Q7, Q9, Q10).
• Strong understanding of data integrity principles (ALCOA+) and global regulatory requirements.
• Ability to travel approximately 20% both domestically and internationally.

Preferred Qualifications

• Advanced degree (MS, MBA, or equivalent).
• Bilingual proficiency in English and Spanish.
• Experience with sterilization processes, microbiological control, and sterility assurance.

About the Company

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.